NCT06915116 Acupuncture for People Experiencing Period Loss Due to Chemotherapy
| NCT ID | NCT06915116 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-03-31 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to find out whether it is practical (feasible) to use acupuncture to treat period loss (amenorrhea) caused by chemotherapy treatment in people with cancer. The researchers will look at how many participants enroll and complete the study. The researchers will also study how treatment with acupuncture affects the amount of time for the menstrual cycle to return and symptoms and quality of life related to amenorrhea.
Eligibility Criteria
Inclusion Criteria: * English speaking woman between the ages of 15 and 40 * History of stage I, II, or III cancer OR stage IV or unstaged hematologic malignancy (e.g. lymphoma, leukemia, myeloma) that is stable, as assessed by care team * Premenopausal status with regular menstruation at the time of diagnosis by patient report * Completed cytotoxic chemotherapy within the past year * Premenopausal status with regular menstruation at the time of diagnosis by patient report for females ages 18 or older * Report cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment. * Have reached menarche prior to therapy or during therapy for females between 15 and 17 years old * Patient reports cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment. * Have been without menses for at least 3 months 64 following the completion of cytotoxic chemotherapy * Willing to adhere to all study-related procedures, including randomization to one of the two possible arms: acupuncture and WLC Exclusion Criteria: * Had been pregnant or lactating within 3 months prior to enrollment * History of hysterectomy or bilateral oophorectomy * Ongoing or planned radiation or surgery within 4 months from randomization * Use of acupuncture for menses recovery within 3 months of enrollment * Had been or will be receiving ovarian suppression medicine, such as leuprolide (Lupron) and goserelin (Zoladex), or hormonal contraception drugs within 3 months of enrollment or during the study period
Contact & Investigator
Jun Mao, MD, MSCE
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06915116 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 40 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06915116 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06915116 currently recruiting?
Yes, NCT06915116 is actively recruiting participants. Contact the research team at maoj@mskcc.org for enrollment information.
Where is the NCT06915116 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT06915116 clinical trial?
NCT06915116 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Jun Mao, MD, MSCE at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 60 participants.
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